08 December 2025 This Week in Health Policy for December 8 The House and Senate are both scheduled to be in session this week, with the Senate expected to hold a vote on the expiring ACA enhanced premium tax credits. House Committee on Oversight and Government Reform will hold a hearing on "Lowering the Cost of Healthcare: Technology's Role in Driving Affordability."
Senate Committee on Homeland Security and Governmental Affairs Subcommittee on Investigations will hold a hearing on "Defining Our Healthcare Problem, and Principles We Should Follow to Solve it."
Senate Health, Education, Labor, and Pensions Committee will hold a hearing on "Future of Organ Network, Strengthening Patients' Access to Lifesaving Organs."
ACA enhanced premium tax credit expiration looms. Lawmakers made little progress this week in reaching a health care deal to prevent premium increases in the Affordable Care Act (ACA) exchange marketplace associated with the expiration of enhanced premium tax credits (PTCs), which are set to take effect on January 1, 2026. On Thursday (December 4), Senate Minority Leader Chuck Schumer (D-NY) announced that Democrats will seek a vote next week on a three-year extension of the enhanced PTCs, following a promise to hold a vote on the issue by Majority Leader John Thune (R-SD) during discussions to end last month's government shutdown. Republicans, meanwhile, have not coalesced around an alternative plan. Discussions are ongoing about leveraging tax-preferred accounts, such as health savings accounts (HSAs), to deliver the tax credits directly to consumers. While a growing number of moderate Republicans have voiced support for a short-term extension, House Speaker Mike Johnson (R-LA) has remained firm in his opposition to holding a vote on an extension, though reports indicate he is working on a potential Republican alternative. National Defense Authorization Act. Republican leadership delayed releasing final bill text for the National Defense Authorization Act this week, as they continue to address last minute policy issues with the White House and members. Policies that remain unresolved include a White House request to address housing costs, as well as whether to include the BIOSECURE Act, and provisions to expand in vitro fertilization and other fertility services for military families under TRICARE. Trump signs SUPPORT Act. On Monday (December 1), President Trump signed into law the SUPPORT for Patients and Communities Reauthorization Act (H.R. 2483), which reauthorizes several programs intended to combat the opioid crisis and improve access to mental health resources for families and children. House passes health-related bills. On Monday (December 1), the House passed under suspension the Hospital Inpatient Services Modernization Act (H.R. 4313), which would extend the Hospital-at-Home Initiative through September 30, 2030. The House also passed under suspension a bill (H.R. 1262) that would reauthorize the Food and Drug Administration's (FDA's) rare pediatric priority review voucher (PRV) incentive program, which expired in late 2024. The bills now go to the Senate. Cassidy sends AMA letter. On Monday (December 1), Sen. Bill Cassidy (R-LA), chairman of the Senate HELP Committee, sent a letter to the American Medical Association (AMA) asking a series of questions regarding the organization's role in setting industry payment rates and billing codes following another inquiry earlier this year. Democrats unveil health care priorities. On Wednesday (December 3), the New Democrat Coalition Health Care Working Group unveiled a Health Care Action Plan that includes 45 policy recommendations that aim to improve the quality and affordability of care, strengthen federal health care programs, and improve access to care. HHS publishes AI Strategy. On Thursday (December 4), the Department of Health and Human Services (HHS) unveiled its AI Strategy, which adopts a "OneHHS" approach to help achieve its goal of integrating AI throughout the Department, including drug reviews and approvals, medical research, and more. The strategy includes five pillars:
FDA to announce changes to clinical trial guidance. On Thursday, STAT News reported that FDA Commissioner Marty Makary confirmed that the agency will soon issue a press release outlining its plans to update clinical trial guidance to begin requiring one clinical study, instead of the standard two clinical trials, for certain medical products before consideration for approval. HHS takes several actions on parental vaccine consent. On Wednesday (December 3), HHS said it has directed the Health Resources and Services Administration (HRSA) to add a grant requirement stating that all funding recipients must comply with all applicable federal and state parental-consent laws for any services or care provided to minors at HRSA-supported health centers. The Department also issued a Dear Colleague letter to health care providers reminding them of existing federal parental-consent laws. The actions come in the wake of an allegation that a school in the Midwest vaccinated a child without the parents' consent. CMS rescinds nursing home staffing requirements. On Tuesday (December 2), CMS formally repealed provisions in a 2024 rule that set federal minimum staffing standards for nursing homes. The interim final rule removes the requirements for nursing homes to provide a minimum of 3.48 hours of nursing care per resident a day and to have 24/7 onsite RN services and reinstates the previous policy requiring facilities to use the services of an RN for at least eight consecutive hours a day, seven days a week and to designate an RN to serve as the director of nursing on a full-time basis except when waived. Those requirements had been delayed until 2034 under the One Big Beautiful Bill Act (OBBBA). The 2024 rule's facility assessment requirements remain in place. The interim final rule takes effect February 2, 2026, and will also remain open for comment until that date. Click here for a press release. FDA RFI on nonprescription drugs. On Tuesday (December 2), the FDA published a request for information seeking feedback on ways the agency could increase patients' access to nonprescription drugs and the challenges faced in developing drugs for nonprescription use. CMS unveils new ACCESS Model. On Monday (December 1), CMS unveiled a new 10-year voluntary model that will test the use of innovative health technologies, such as telehealth, for managing chronic disease in Medicare. The Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model will focus on select conditions: high blood pressure, diabetes, chronic musculoskeletal pain, and depression. CMS said the model will begin July 1, 2026, and the agency will begin accepting applications on January 12, 2026. Clinicians will have until April 1, 2026, to apply. In concert with the ACCESS model, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety. ACIP votes to change hepatitis B schedule. On Friday (December 5), ACIP voted 8-3 to end the blanket recommendation that all infants get the hepatitis B vaccine at birth, maintaining that guidance only for infants whose mothers test positive for the infection or have unknown status. The change would take effect if endorsed by the Centers for Disease Control and Prevention (CDC). US and UK reach deal on drug pricing, pharma tariffs. On Monday (December 1), the Office of the U.S. Trade Representative announced that the U.S. will exempt the United Kingdom from any tariffs on pharmaceuticals contemplated by the Trump administration in exchange for an agreement by the UK to raise the net price it pays for new drugs by 25% and cap the clawback tax that applies to branded drugs to 15%. The tariff exemptions include not only full relief from the Section 232 investigation into pharmaceuticals and drug inputs, but also relief from the Section 232 investigation into medical devices/technologies and a commitment to not target UK drug pricing practices via a Section 301 investigation. Officials did not provide a timeline for finalizing the deal but said implementation would begin in 2026. Trump EO launches new AI initiative. On November 24, President Trump signed an executive order to launch the Administration's "Genesis Mission" — an initiative led by the Department of Energy with guidance from the White House Office of Science and Technology Policy to accelerate the adoption of AI in science, including biotechnology. CMS issues the CY 2026 Home Health Prospective Payment System final rule. On November 28, CMS issued a final rule that includes a 1.3% payment cut, or $220 million, for home health providers in CY 2026 as compared to CY 2025. CMS initially proposed a 6.4% payment cut for home health care, citing the agency's plan to recoup retrospective overpayments totaling $4.7 billion. CMS in the final rule said it decided to reduce the reduction in response to comments. The rule also finalized changes to payments for continuous glucose monitors, face-to-face encounters, the Home Health Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program, and more. Click here for the fact sheet. Click here for a fact sheet on the competitive bidding updates. CMS issues MA, Part D Policy and Technical Changes proposed rule. On November 25, CMS issued a proposed rule that includes policy and technical changes to the Medicare Advantage (MA) and Part D programs for contract year 2027. The rule proposes updates to special enrollment periods to allow for changes when a patient's provider leaves their plan's network, removes requirements for MA utilization management committees to include a health equity expert, and MA quality improvement programs to include activities to reduce health disparities. In addition, the rule would remove a requirement for MA plans to send mid-year notices related to unused supplemental benefits. The rule also makes several changes to MA Star Ratings, including eliminating the Excellent Health Outcomes for All (EHO4All) reward along with 12 measures largely focused on operational and administrative performance and add a new depression screening and follow-up measure to address behavioral health gaps. The proposed rule also includes requests for information on Competition and risk adjustment, C-SNPs vs. D-SNPs, and well-being and nutrition. Click here for the press release. Click here for the fact sheet. CMS publishes MFPs for Part D drugs. On November 25, CMS published the maximum fair prices (MFPs) of the 15 Medicare Part D drugs subject to the second round of the Medicare drug price negotiation program. The published data show CMS negotiated discounts ranging from 38% to 83% on the selected drugs, which included treatments for Type 2 diabetes, obesity, asthma and chronic obstructive pulmonary disease, cancers, and more and accounted for about $42.5 billion in total gross covered prescription drug costs under Medicare Part D in 2024. The MFPs for the 15 Part D drugs will take effect on January 1, 2027. Click here for a fact sheet. CMS separately announced that three drugs will be removed from Medicare's price negotiation program in 2027 after regulators determined they now face generic or biosimilar competition. CMS issues notice on data sharing with ICE. On November 25, CMS published a notice in the Federal Register announcing its intent to resume sharing Medicaid enrollment data with Immigration and Customs Enforcement (ICE). The notice addresses a preliminary injunction that blocked the agency from implementing the data-sharing policy in 20 states by providing a rationale for the policy. ASTP/ONC issues enforcement discretion. On November 24, the Assistant Secretary for Technology Policy (ASTP) and the Office of the National Coordinator for Health Information Technology (ONC) said effective immediately it will exercise enforcement discretion for certified health IT developer attestations for the period covering April 2025 through September 2025, which were due October 31, 2025. The enforcement discretion, which was issued in response to the government shutdown, will remain in place until January 1, 2026. Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on "Making Health Care Affordable Again: Healing a Broken System." On Wednesday (December 3), the Committee held a hearing that largely focused on the ACA's enhanced premium tax credits expiring at the end of the year. During the hearing, all Democrats and a few Republicans stated they would support at least a short-term extension of the premium tax credits while lawmakers work on bipartisan reforms. However, most Republicans voiced their opposition to an extension, favoring instead proposals to create new tax-preferred accounts, funding the ACA's cost-sharing reduction payments (CSRs), and increasing transparency in health care to give consumers more control over their health care decisions.
Senate Special Committee on Aging held a hearing on "Aging in Place: The Impact of Community during the Holidays." On Wednesday (December 3), the Committee held a hearing during which members heard from witnesses who spoke about the importance of reauthorizing the Older Americans Act. Members expressed bipartisan support for the legislation with Republican members also expressing support for policies like tax credits for caregivers in multigenerational homes and Democrats raising concerns about future Medicaid cuts.
House Ways and Means Oversight Subcommittee held a hearing on "Lives at Stake: Holding Tax-Exempt Organ Procurement Organizations (OPOs) Accountable." On Tuesday (December 2), the Subcommittee held a hearing during which they heard from a panel of witnesses that included an organ donor family member, a former OPO employee, a policy expert, and economist. During the hearing, members and witnesses called for more accountability and transparency into OPOs, which the committee is investigating amid reports of improper clinical practices, misuse of taxpayer dollars, and more.
Document ID: 2025-2441 | |||
